From Nerve to Brain: Toward a Mechanistic Understanding of Spinal Cord Stimulation in Human Subjects
Start Date
6/8/2023
Completion Date
8/31/2027
Summary
This is a multicenter prospective study of patients who currently have stably implanted spinal cord simulators. Patients will be randomly assigned to turn on or off their spinal cord stimulators for two week intervals up to six weeks after enrollment, and on the final day of study participation, for one hour intervals, in a multi-crossover design. In a subset of patients we will also perform combined positron emission tomography/magnetic resonance imaging at baseline, week 2 and week 4.
Detailed Description
The fundamental hypothesis for this study is that spinal cord stimulators modulate the excitability of primary afferent neurons to reduce pain, and that these changes can be detected by measurement of axonal excitability. For the primary outcome, the study investigators will leverage the sensitivity and reproducibility of threshold tracking nerve conduction studies to detect changes in the excitability of thickly myelinated nerve fibers. The study investigators will use microneurography to record directly from primary nociceptive afferents. Finally, the study investigators will perform plasma inflammatory cytokine profiles to measure changes due to spinal cord stimulators. By correlating changes in outcome measurements with subject pain levels during therapeutic versus minimal spinal cord stimulators settings, this study will determine which effects may be mechanistically relevant and which are unrelated to reduction in pain. Thus, this study will use robust, reproducible techniques to define the peripheral, central, and systemic effects of spinal cord stimulators.
Eligibility Criteria
Age Range: 18 years to 80 years
Interventions
Spinal Cord Stimulator Set to Minimal/No Stimulation Setting
Usual Care
Positron Emission Tomography / Magnetic Resonance Imaging
Conditions
Locations
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States
Brigham and Women's Hospital
Boston, Massachusetts 02215
United States